A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
|ClinicalTrials.gov Identifier: NCT01598311|
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : February 27, 2018
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: CB-183,315 Drug: Vancomycin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||608 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea|
|Actual Study Start Date :||May 16, 2012|
|Actual Primary Completion Date :||July 26, 2015|
|Actual Study Completion Date :||August 25, 2015|
Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days.
CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.
Other Name: SurotomycinDrug: Placebo
Placebo size 00 opaque hard gelatin capsules.
Active Comparator: Vancomycin
Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.
- Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT) [ Time Frame: Up to 3 days after EOT (up to Day 13) ]The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or >200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
- Percentage of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 30 days after EOT (up to Day 40) ]An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
- Percentage of Participants Discontinuing From Study Treatment Due to an AE [ Time Frame: Up to EOT (up to Day 10) ]An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
- Number of Clinical Failure Events up to Day 40 [ Time Frame: Up to 30 days after EOT (up to Day 40) ]The total number of clinical failure events, which included treatment failure, CDAD recurrence, death, or being lost to follow-up, occurring during each time period was determined in each arm.
- Adjusted Percentage of Participants With Sustained Clinical Response at End of Study [ Time Frame: Up to 40 days after EOT (up to Day 50) ]The percentage of participants with sustained clinical response was determined for each arm. Sustained clinical response was declared when participants had a clinical outcome of cure at EOT, did not experience any CDAD recurrence, did not die, were not lost to follow-up, and did not have the end of study visit prior to Day 40. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598311
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|